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A Validation Study of the German Autobiographical Memory Interview

Primary Purpose

Retrograde Amnesia

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
German Autobiographical Memory Interview short-form
Sponsored by
Rheinhessen-Fachklinik Alzey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Retrograde Amnesia focused on measuring Electroconvulsive therapy, Depression, Cognitive side effects

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • MDD
  • HDRS > 17
  • Age 18-80
  • Ability to give informed consent

Exclusion Criteria:

  • Drugs or drug abuse or addictions
  • Use of benzodiazepine equivalent to lorazepam> 1.5 mg per day
  • Cognitive impairments
  • History of traumatic brain injury
  • Relevant organic disease, e.g. Multiple sclerosis, Parkinson's disease
  • Bipolar illness, dementia or schizophrenic disorder
  • German is not the mother tongue
  • Inability to give informed consent

Sites / Locations

  • Rheinhessen-Fachklinik AlzeyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Patients with depression

Healthy controls

Arm Description

Major depression according to DSM-V and ICD-10 (ICD F32.1, F32.2, F32.3, F33.1, F33.2, F33.3) Hamilton Depression Rating Scale > 17

- Mental health

Outcomes

Primary Outcome Measures

German Autobiographical Memory Interview short-form
Changes in autobiographical memory measured with the German Autobiographical Memory Interview short-form pre-post in depressed patients vs. a healthy control Group.

Secondary Outcome Measures

Hamilton Depression Rating Scale (HAMD-17)
Change in depression severity
Inventar Depressiver Symptome (IDS)
Change in depression severity
36-item Health Survey (SF-36)
Change in qualtiy of life
Global Self-Evaluation-Memory (GSE-My)
Change in self-evaluation of memory

Full Information

First Posted
August 11, 2020
Last Updated
August 17, 2020
Sponsor
Rheinhessen-Fachklinik Alzey
Collaborators
Johannes Gutenberg University Mainz
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1. Study Identification

Unique Protocol Identification Number
NCT04516863
Brief Title
A Validation Study of the German Autobiographical Memory Interview
Official Title
Validation of the German Short Version of the Autobiographical Memory Interview in Patients With Depression and Healthy Controls
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
May 1, 2021 (Anticipated)
Study Completion Date
May 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rheinhessen-Fachklinik Alzey
Collaborators
Johannes Gutenberg University Mainz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Electroconvulsive therapy (ECT) is recommended for the treatment of severe depression. But, despite the high remission rates the use of ECT is strongly limited by the social stigma and treatment-emergent cognitive side effects in patients. The most relevant is retrograde amnesia (RA), because it can persists for months and years. To measure RA after ECT the short-form of the Autobiographical Memory Interview (SF-AMI) is commonly used. However, the validation of the German SF-AMI has not yet been carried out. Thus, the aim of this study is to validate the German SF-AMI in depressed patient and healthy controls. The investigators hypothesize that the German SF-AMI is reliable and valid to quantify RA.
Detailed Description
To measure retrograde amnesia of autobiographical memory after ECT, various tests were used so far. Currently, the short form of the Autobiographical Memory Interview (AMI-SF) was used most frequently internationally. In Germany there is no validated translation of the AMI-SF. However, in order to be able to systematically record the cognitive side effects of ECT in clinical practice as well as in research in the German-speaking area, it is important to have validated test procedures that can be successfully used in repeated measurements. In this study, the German version of the AMI (D-AMI), i.e. the specificity of the German short version of the autobiographical memory in patients with depression will be investigated. It is also known in healthy people that autobiographical memory contents can no longer be called up over time. Therefore, the aim of this study is to investigate whether a change in autobiographical memory over the course of time in depressed patients differs from healthy control subjects. It should also be shown whether this German short version for examining autobiographical memory (D-AMI) can be carried out.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retrograde Amnesia
Keywords
Electroconvulsive therapy, Depression, Cognitive side effects

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with depression
Arm Type
Active Comparator
Arm Description
Major depression according to DSM-V and ICD-10 (ICD F32.1, F32.2, F32.3, F33.1, F33.2, F33.3) Hamilton Depression Rating Scale > 17
Arm Title
Healthy controls
Arm Type
Active Comparator
Arm Description
- Mental health
Intervention Type
Diagnostic Test
Intervention Name(s)
German Autobiographical Memory Interview short-form
Other Intervention Name(s)
D-AMI
Intervention Description
Diagnostic Test
Primary Outcome Measure Information:
Title
German Autobiographical Memory Interview short-form
Description
Changes in autobiographical memory measured with the German Autobiographical Memory Interview short-form pre-post in depressed patients vs. a healthy control Group.
Time Frame
pre-post (six weeks)
Secondary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (HAMD-17)
Description
Change in depression severity
Time Frame
pre-post (six weeks)
Title
Inventar Depressiver Symptome (IDS)
Description
Change in depression severity
Time Frame
pre-post (six weeks)
Title
36-item Health Survey (SF-36)
Description
Change in qualtiy of life
Time Frame
pre-post (six weeks)
Title
Global Self-Evaluation-Memory (GSE-My)
Description
Change in self-evaluation of memory
Time Frame
pre-post (six weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: MDD HDRS > 17 Age 18-80 Ability to give informed consent Exclusion Criteria: Drugs or drug abuse or addictions Use of benzodiazepine equivalent to lorazepam> 1.5 mg per day Cognitive impairments History of traumatic brain injury Relevant organic disease, e.g. Multiple sclerosis, Parkinson's disease Bipolar illness, dementia or schizophrenic disorder German is not the mother tongue Inability to give informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah PD Dr. med. MSc. Kayser, MD
Phone
+ 49 6731 50 1278
Email
s.kayser@rfk.landeskrankenhaus.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah PD Dr. med. MSc. Kayser, MD
Organizational Affiliation
Rheinhessen-Fachklinik Alzey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rheinhessen-Fachklinik Alzey
City
Alzey
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55232
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Kayser, MD
Phone
+49 6731 50 1278
Email
s.kayser@rfk.landeskrankenhaus.de

12. IPD Sharing Statement

Plan to Share IPD
No

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A Validation Study of the German Autobiographical Memory Interview

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